Cleared Traditional

K832905 - QUALITATIVE ENZYME IMMUNOASSAY-DETECT

K832905 is an FDA 510(k) clearance for QUALITATIVE ENZYME IMMUNOASSAY-DETECT, manufactured by Btc Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K832905 · Btc Diagnostics, Inc. · Chemistry device
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Feb 1984
Decision
158d
Days
Class 2
Risk

K832905 is an FDA 510(k) clearance for the QUALITATIVE ENZYME IMMUNOASSAY-DETECT. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Btc Diagnostics, Inc. (Walker, US). The FDA issued a Cleared decision on February 3, 1984 after a review of 158 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Btc Diagnostics, Inc. devices

FDA 510(k) Submission Details - K832905

510(k) Number K832905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1983
Decision Date February 03, 1984
Days to Decision 158 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 88d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCX Device Classification - Class 2, Special Controls

Product Code LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - LCX Kit, Test, Pregnancy, Hcg, Over The Counter

All 176
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K832905.
ANSWER ONE-DAY
K843238 · Armkel, LLC · Sep 1984
BETA STICK, PREGNANCY TEST
K841415 · Quidel Corp. · Jul 1984
ACCURATE BETA 30 PREGNANCY TEST KIT
K841602 · Organon, Inc. · May 1984
EARLY PREGNANCY DETECTION TEST KIT
K833466 · Quidel Corp. · Nov 1983
HOME PREGNANCY TEST KIT HPK #1
K831051 · Quidel Corp. · May 1983
HOME PREGNANCY TEST KIT
K831108 · Quidel Corp. · May 1983